Senior Manager

3 weeks ago


Leeds, Leeds, United Kingdom MAC Clinical Research Full time
Job Title: Senior Manager

We are seeking a highly skilled Senior Manager to join our team at MAC Clinical Research. As a Senior Manager, you will be responsible for leading and delivering comprehensive production services, including aseptic services, and ensuring compliance with Good Manufacturing Practice (GMP) regulations.

Key Responsibilities:
  • Lead and deliver comprehensive production services, including aseptic services
  • Ensure compliance with GMP regulations
  • Train production staff
  • Liaise with staff, sponsors, vendors, and customers regarding requirements for studies of Investigational Medicinal Product (IMP) / commercial and comparator
  • Ensure that products are produced and stored according to the appropriate documentation so that they reach the appropriate standards of quality
  • Approving the instructions relating to production operations and ensure their strict implementation
  • Ensure that the production records are evaluated and signed by an authorised person before they are sent to Quality Control (QC) Department
  • Ensure that the required initial and continuing training of their department personnel is carried out and adapted according to need
  • The monitoring and control of the manufacturing environment
  • Ensure plant hygiene standards are maintained
  • The approval and monitoring of suppliers of materials
  • The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activates
  • The designation and monitoring of storage condition of materials and products
  • The monitoring of compliance with the requirements of good manufacturing practice
  • The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality
  • Participation in management reviews of processes performance, product quality and of the quality management system and advocating continual improvement
  • Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management
  • Compliance with MAC health and Safety policy
  • Compliance with MAC policy on equality and diversity
  • To maintain professional qualifications required for the role, including continuous personal development
  • To work according to MAC SOPs, guidelines and policies
  • To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business related data.
Requirements:
  • Required to travel to individual MAC Research sites as appropriate for training, equipment issues and client visits
  • Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
  • Health Insurance
  • Free onsite parking
  • 25 days annual leave (increasing in increments to 30 days after 6 years' service)
  • Your birthday off work


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